IMP handling [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-05-09 03:08 (2595 d 10:22 ago) – Posting: # 17330
Views: 30,290

Hi mittyri,

❝ I suppose the problem could be not in the case of 'significant separation in time' but in case of some mistakes in IMP handling.

❝ For example, RIMP has a proven stability up to 30C and TIMP up to 25 only. Due to some "why bother" attitude the designated employee missed it. As a result the second group will be treated with poor TIMP. I assume here that the order of groups treatment is

❝ GR1PER1

❝ GR1PER2

❝ GR2PER1

❝ GR2PER2


[image]That’s what I would call a “stacked approach”.
IMHO, not a good idea for single dose but might be necessary in steady state studies if the capacity of the clinical site is limited.

❝ The CRO's are usually mixing the time for groups for more effective time management.


[image]Yep – the “staggered approach” keeps the interval as short as possible.


60% of my data sets had an interval of less then seven days. In most of my single dose studies the interval was one to three days.

❝ So I think in case of appropriate IMP handling we wouldn't observe any real (not false-positive) interaction.


Agree.

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